The Efficacy of PRP Combined With Exercise to Treat Knee Osteoarthritisq

NCT05585216 | Completed

• 1 other identifier: QIE001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Objective. In this study, the investigators aimed to investigate the efficacy of combined a single platelet-rich plasma (PRP) and physical exercise (leg swing and quadriceps strengthening exercise) versus PRP and hyaluronic acid (HA) combination therapy. Methods. One hundred and six patients with grade Ⅱ-Ⅲ Knee osteoarthritis (KOA) according to the Kellgren-Lawrence classification were randomly divided into intra-articular injection of PRP combined with leg swing and quadriceps strengthening exercise (group A) and intra-articular combination injections of PRP and HA (group B). Patients in group A received twice intra-articular injection of PRP (2 ml, 2 weeks apart) and regular leg swing and quadriceps strengthening exercise for 3 months. Patients in group B received twice intra-articular combination injections of PRP (2 ml) and HA (2 ml) every 2 weeks. The primary outcome measures were Visual Analogue Scale (VAS) and Western Ontario and McMaster Universities (WOMAC) score. The second outcomes included single leg stance test (SLS) and functional activity by 2 minutes walking test (2MWT) and time up and go test (TUGT). All outcomes were evaluated at baseline and after 1,3,6, and 12 months.

Conditions

Platelet-rich Plasma; Physical Exercise; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Visual Analogue Scale (VAS)

  Degree of knee pain during treatment

  12 months

• Western Ontario and McMaster Universities (WOMAC) score

  Severity of knee osteoarthritis

  12 months

Secondary Outcomes (3)

• single leg stance test (SLS)

  12 months

• 2 minutes walking test (2MWT)

  12 months

• time up and go test (TUGT)

  12 months

Study Arms (2)

PRP combined with leg swing and quadriceps strengthening exercise

EXPERIMENTAL

Group A received twice intra-articular injection of platelet-rich plasma (2 ml, 2 weeks apart) and regular leg swing and quadriceps strengthening exercise for three months.

Drug: platelet-rich plasma

intra-articular combination injections of PRP and HA

ACTIVE COMPARATOR

Group B received twice intra-articular combination injections of PRP (2 ml) and HA (2 ml) every 2 weeks.

Drug: platelet-rich plasma

Interventions

platelet-rich plasma DRUG

intra-articular combination injections of platelet-rich plasma and hyaluronic acid or intra-articular combination injections of PRP combined with leg swing and quadriceps strengthening exercise

PRP combined with leg swing and quadriceps strengthening exercise; intra-articular combination injections of PRP and HA

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged ≥ 45 years old;
• KOA was diagnosed according to the American College of Rheumatology Classification Criteria;
• patients with the Kellgren-Lawrence grade (K-L grade) for KOA of Ⅰ-Ⅲ;
• a history of symptoms more than three month, and patients with independent mobility.

You may not qualify if:

• lower limb axial deviation large than 5° (valgus and varus knee);
• patients with diabetes mellitus, sever cardiovascular disease, immunosuppressive status, mental illness or other diseases than might affect the results;
• injections or other invasive treatments into the lower extremities were used in the past three months;
• patients willing to follow the doctor's recommendation for exercise training;
• patients with previous knee fracture or malignancy;
• patients with a previous history of hip or knee joint surgery;
• patients participating in hip or knee muscle strengthening in the past 3 months;
• patients did not complete the intervention strategies or regular follow-up.

Sponsors & Collaborators

• Hebei Medical University Third Hospital: lead

Study Sites (1)

the Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

MeSH Terms

Conditions

Motor Activity; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Behavior; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2022
• First Posted: October 18, 2022
• Study Start: January 1, 2021
• Primary Completion: August 31, 2021
• Study Completion: October 1, 2021
• Last Updated: October 20, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)